Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant

Be female, between 18 and 65 years of age at the time of enrollment

Exclusion Criteria:

Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study

Have undergone a skin reducing mastectomy

Have a BMI that is <17 or ≥ 30

Predicted implant weight more than 500 grams

Have a known allergy to silk

Have an abscess or active infection at any location within one month prior to surgery

Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study